The image part with relationship ID rId2 was not found in the file.

COVID-19 Vaccine Safety Technical (VaST) 

Work Group 

Assessment

Grace M. Lee, MD MPH (ACIP Chair)

Robert H. Hopkins, Jr., MD (NVAC Chair)

Advisory Committee on Immunization Practices

July 22, 2021
The image part with relationship ID rId2 was not found in the file.

COVID-19 Vaccination in the United States

 338 million doses 

administered

 161 million individuals 

fully vaccinated

https://www.nytimes.com/2021/07/19/briefing/vaccine-skepticism-vaccination-drive.html
The image part with relationship ID rId2 was not found in the file.

Vaccine Safety in Numbers
The image part with relationship ID rId2 was not found in the file.

VaST Activities

Dec Jan Feb Mar Apr May Jun Jul

Dec 12 

Pfizer

(16+)

Feb 28 

Janssen 

(18+)

Apr 14 

CVST 

following 

Janssen

Dec 19 

Moderna 

(18+)

Apr 23 

TTS 

updates; 

Janssen 

resumed 

with 

warning

May 12 

Pfizer

(12-15)

Jan 27

Anaphylaxis 

following 

mRNA 

vaccines

Mar 1

Anaphylaxis 

updates;

Pregnancy 

vaccine safety 

data

May 12

TTS 

updates

Jun 23

Myocarditis

updates

May 17 

& 24

Myocarditis

ACIP votes 

following 

EUA

VaST 

assessments 

at ACIP 

meetings or 

website

Jun 28

GBS 

following 

Janssen

Dec 21, 2020 – present:

• 28 independent meetings to review vaccine safety data

• 6 joint meetings with COVID-19 Vaccines Work Group focused on safety

CVST, cerebral venous sinus thrombosis; TTS, thrombosis with thrombocytopenia syndrome 4
The image part with relationship ID rId2 was not found in the file.

VaST Work Group Report – June 28

 In VAERS

–

–

–

–

Observed number of preliminary cases of GBS after Janssen vaccine was 

greater than the expected number

• All age groups; no geographic clustering

Observed versus expected reporting rates not elevated for the mRNA 

vaccines

 In VSD and VA RCAs

No statistical signals for GBS for any COVID-19 vaccine

However, the rate of GBS following Janssen was higher than for mRNA 

vaccines in VSD

5

https://www.cdc.gov/vaccines/acip/work-groups-vast/index.html; 

VSD, Vaccine Safety Datalink; VA, Veteran’s Administration
The image part with relationship ID rId2 was not found in the file.

VaST Work Group Report – June 28 (continued)

 GBS cases reported after receiving AstraZeneca COVID-19

vaccine, which is used in other countries

 VaST members discussed need for:

–

–

Review and adjudication of VAERS case reports of GBS using

Brighton collaboration criteria

Ongoing monitoring of GBS among persons who received the

Janssen COVID-19 vaccine in the United States

6

https://www.cdc.gov/vaccines/acip/work-groups-vast/index.html

https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-8-july-2021

https://brightoncollaboration.us/guillain-barre-and-miller-fisher-syndromes-case-definition-companion-guide/
The image part with relationship ID rId2 was not found in the file.

Regulatory Agency Updates

 July 9 – EMA announced the addition of a warning for GBS 

following Astra Zeneca COVID-19 vaccine

 July 12 – FDA announced revisions to the Janssen COVID-19 

vaccine EUA fact sheets for providers and patients to include 

information about an observed increased risk of GBS following 

vaccination

7

https://www.fda.gov/media/146304/download

https://www.janssenlabels.com/emergency-use-authorization/Janssen+COVID-19+Vaccine-Recipient-fact-sheet.pdf
The image part with relationship ID rId2 was not found in the file.

VaST Meetings – July 12 and July 19 

8

COVID-19 

vaccine

Crude reporting 

rates in VAERS

Unadjusted, chartconfirmed rates in VSD 

Janssen 8.1 20.2

mRNA 1.1 0.7

~1.6 cases of GBS per million doses expected

 Background rates of GBS generally increase with age and greater in 

males than females

GBS per million doses administered in VAERS and VSD, 18+ years
The image part with relationship ID rId2 was not found in the file.

VaST Discussion and Interpretation - GBS

 Risk for GBS following Janssen is substantially different than 

either the risk following mRNA COVID-19 vaccines or expected 

background rates

–

–

Median onset of 13 days in VAERS; males > females

 Fewer individuals receive Janssen in the U.S. (<4% of all doses 

administered)

 GBS cases following SARS-CoV-2 infection also reported*

Median onset ~12-14 days post-infection

*Aldawi et al., Can J Neurol Sci 2021; Sheikh et al., J Neuroimmunol 2021; Sriwastava, J Neurol Sci 2021 9
The image part with relationship ID rId2 was not found in the file.

VaST Discussion and Interpretation - GBS

 Medical record review of VAERS cases in process using 

Brighton collaboration criteria

– Need to confirm the diagnosis of GBS and further 

characterize the clinical presentation, severity and 

outcomes of GBS cases following Janssen vaccine 

 Continue to assess the benefit-risk analyses, given the 

dynamic epidemiology of COVID-19 infection

10
The image part with relationship ID rId2 was not found in the file.

Monitoring and Responding to Safety Data

11

Safety monitoring

• mRNA COVID-19 vaccines 

– Anaphylaxis

– Myocarditis

• Janssen COVID-19 vaccine

– TTS

– GBS

• Pre-specified AESI

• Communication between 

agencies

Incorporating safety data into decision-making

 Dynamic benefit-risk balance

 Risk mitigation strategies

– Support informed discussions about benefits 

and risks of available vaccines

– Clinical guidance to support early detection 

and appropriate management
The image part with relationship ID rId2 was not found in the file.

VaST Members

VaST Members

Grace Lee (ACIP)

Robert Hopkins (NVAC)

Matt Daley

Veronica McNally

Keipp Talbot

Kathy Edwards

Lisa Jackson

Jennifer Nelson

Laura Riley

Robert Schechter

Patricia Whitley-Williams

CDC Co-Leads

Lauri Markowitz

Melinda Wharton

Ex Officio and Liaison Representatives 

Tatiana Beresnev (NIH)

Karen Farizo; Hui Lee Wong (FDA)

Judith Steinberg (OIDP)

Jeffrey Kelman (CMS)

Matthew Clark (IHS)

Mary Rubin (HRSA)

Fran Cunningham (VA)

Limone Collins (DoD)

Administrative Support

Jared Woo

12 12